Process Engineering Specialist
Los Angeles, CA
Req ID 50651BR
Business Title
Process Engineering Specialist
Business
BioScience
Sub-Business
Manufacturing
Country
US
State/Province
California
Location of Position
Los Angeles, CA
Shift_
1st
Job Description
""This position is responsible for managing process engineering projects related to the Los Angeles Master Plan (LAMP). Lead scope definition /clarification exercises to properly and completely characterize project requirements. Position responsible for project-related functions including conceptual design, specifications, budgeting, scheduling, construction management, start up and commissioning. Project scope requires an in depth knowledge of biologics and/or pharmaceutical construction requirements related to process equipment, HVAC , purified water systems (R.O., WFI), computer/automation, and general working GMP knowledge of pharmaceutical manufacturing facilities and all major utilities. Experience with plasma purification is strongly desired. Knowledge of cleanroom design and facilities preferred.
Provide guidance, review and direction as necessary to create relevant and functional Life Cycle and other documentation in accordance with cGMPs, Baxter and BioScience Quality Systems standards for commissioning and validation of systems. Provide guidance and direction to contractors so as to meet projects schedule and financial goals while ensuring technical success.
Apply specialized knowledge to achieve a technical vision for research, design or process strategies where clear precedents do not exist and creative thinking is required. Generate innovative solutions to highly complex problems where little clear precedence exists.
•Review and approve the process and support equipment and systems Design Drawings and Documents and Equipment Procurement Packages
•Provide or lead efforts to ensure Process submittals are reviewed and approved for technical content in accordance with project schedule requirements
•Provide leadership to assess and provide guidance and risk assessments regarding requirements for redundancies to equipment, controls and systems.
•Communicate/coordinate with Los Angeles Engineering and other departments to ensure successful transfer/integration of design, documents and design intent to the plant.
•Applies state of the art techniques in the area of expertise to develop new or improved products and processes.
•May lead a large scale program or several small projects with complex features.
•Performs financial planning and assists in the analysis to justify project approval.
•Independently plans, schedules and leads cross-functional team in detailed phases of the engineering work in a project.
•May supervise one or more engineers or technicians. B.S. degree in Engineering and 10-13 years of experience, M.S. in Engineering preferred and 7-10 years of experience or Ph.D. in Engineering and 4-7 years experience.""
Job Requirements
•Experience in biologics or pharmaceutical facilities, specifically plasma fractionation and purification, design, installation and commissioning for projects.
•Expertise in Batch Processing design.
•Experience and Understanding of the Design, Build and Validation process for large renovations or new facilities.
•Experience implementing Lean Manufacturing concepts.
•Must have experience or advanced training and demonstrate proficiency (e.g., computer-aided design, statistical methods, problem analysis and resolution, materials science, risk-based qualification, design of experiments, software development).
•Experience in CIP and scheduling of Process Operations would be a plus
•Completely proficient in process design processes.
•Successful track record of managing wide-ranging activities within the business unit.
•Demonstrates leadership skills.
•Recognized as a technical expert by peers and other personnel within the business unit.
•Extensive cross-functional team experience, including technical and non-technical work.
•Ability to organize and present technical and project mgt. overviews without assistance. MS and 7 - 10 years specialized experience or Ph.D. and 4 - 7 years specialized
experience.
Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.
